Closed fluid transfer system

ABSTRACT

A closed fluid transfer system for fluidly interconnecting a syringe to any one of a patient I.V. set, a vial and an I.V. bag, is provided and includes a first adapter defining a lumen and supporting a seal across a first end of its lumen, the first adapter supporting a rear end of a needle within the lumen, wherein the seal is movable relative to the needle such that a tip of the needle penetrates through the seal; and a second adapter defining a lumen and supporting a seal across a first end of its lumen; wherein when the second adapter is coupled to the first adapter, the second adapter seal abuts the first adapter seal and moves the first adapter seal relative to the tip of the needle such that the tip of the needle penetrates through the abutting first adapter seal and second adapter seal.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a 35 U.S.C §371 National Phase Filingclaiming the benefit of and priority to International Application No.PCT/US2011/037873, filed on May 25, 2011, which claims the benefit ofand priority to each of U.S. Provisional Application Ser. No.61/348,820, filed on May 27, 2010; U.S. Provisional Application Ser. No.61/348,832, filed on May 27, 2010; U.S. Provisional Application Ser. No.61/419,029, filed on Dec. 2, 2010; and U.S. Provisional Application Ser.No. 61/419,039, filed on Dec. 2, 2010; the entire content of each ofwhich being incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to closed fluid transfersystems and their related components, and more particularly, tocomponents and systems for the transfer of gases/liquids/fluid or othersubstances from a first container to a second container whilemaintaining a closed system.

2. Background of Related Art

In one instance, hazardous medicines are frequently applied in thetreatment of certain diseases, in particular, for example, in thetreatment of cancer. Cytotoxic drugs have generally been used to killcancer cells. However, the use of cytotoxic drugs, in the treatment ofcancer cells, presents specific dangers to all cells, both in thepatient and in healthcare providers. Although the exposure to a healthcare provider is normally very small for each cytotoxic drug doseadministration, evidence suggests that chronic, low-dose exposure canproduce significant health problems. Accordingly, a system that allowsthe safe handling of hazardous drugs while significantly reducing and/oreliminating the exposure to providers would be of great benefit.

Drugs are typically supplied in glass or plastic vials that are cappedwith a gas impermeable liquid seal or stopper. In some instances, thevial contents are a solid powder, such that a liquid needs to beinjected for mixing (e.g., reconstitution). The injection of additionalcontents (e.g., liquid) into the vial produces an increased pressurewhich stresses the seal or stopper. Although the vial is intended to besealed to liquid and gases, drug molecules in vapor phase can leak orpass around the sides of the stopper or through the stopper as theinjection needle is withdrawn, thus presenting a hazard to the provideror clinician.

Accordingly, with the potential for aerosol leakage, leakage/sprayingupon needle withdrawal, or spills, a means with which to prevent theaccidental vapor phase drug egress is required.

Thus, the need exists for new components and systems capable oftransferring gases/fluids/liquids or other substances between aconventional syringe and one of a vial, a patient I.V. (intra-venous)set, or an I.V. bag without leaking or spilling and without exposure ofthe liquids to substances outside the closed system. As such, healthcarepersonnel may more safely use and handle fluid substances includingpotentially hazardous liquids and the like.

SUMMARY

The present disclosure relates to components and systems for thetransfer of a fluid/substance from a first container to a secondcontainer while maintaining a closed system.

According to an aspect of the present disclosure, a closed fluidtransfer system for fluidly interconnecting a syringe to at least one ofa patient I.V. set, a vial and an I.V. bag is provided. The closed fluidtransfer system comprises a syringe adapter including a housing definingan open distal end and an open proximal end, the housing defining a pairof opposed longitudinally extending slots opening from the open distalend of the housing, the housing including a pair of opposedlongitudinally extending ribs projecting from an inner surface thereof;a base supported in the open proximal end of the housing and including aluer connector; a collar slidably and rotatably supported in thehousing, the collar defining a longitudinal opening therethrough, thecollar defining a pair of opposed L-shaped tracks formed in an outersurface thereof and configured to receive a respective longitudinallyextending rib therein, the collar defines a pair of opposed helicaltracks opening from a distal surface of the collar, the opposed helicaltracks being aligned with a respective slot of the housing when thecollar is in a distal-most position; a shuttle slidably extendingthrough longitudinal opening of the collar, the shuttle defining a lumenextending longitudinally therethrough; a barrel supported on andextending over a distal end of the shuttle, the barrel defining acentral opening aligned with the lumen of the shuttle; a biasing memberinterposed between the collar and the shuttle for urging the collar awayfrom the shuttle; a seal interposed between the shuttle and the barrel,wherein the seal extends across the lumen of the shuttle and the centralopening of the barrel; and a needle defining a lumen therethrough, theneedle having a proximal end supported in the base such that the lumenof the needle is in fluid communication with the luer connector, theneedle having a sharpened distal tip disposed within the lumen of theshuttle when the shuttle is in a distal-most position.

The closed fluid transfer system further comprises another adapter forfluidly interconnecting the syringe adapter to one of the patient I.V.set, the vial and the I.V. bag. The another adapter includes a male stemfor selectively connecting to and insertion into the open distal end ofthe syringe adapter, the male stem defining a lumen extendingtherethrough; a pair of opposed guide pins extending radially outwardfrom the male stem; a pair of opposed guide surfaces extending radiallyoutward from the male stem at a location proximal of the guide pins andbeing in registration with the guide pins; and a seal extending acrossthe lumen of the male stem.

In use, the syringe adapter is movable from a closed state to an openstate. In the closed state the tip of the needle is disposed within thelumen of the shuttle, the shuttle is disposed at the distal-mostposition, and the collar is disposed at a distal-most position.

The syringe adapter is movable from the closed state to the open stateby inserting the guide pins of the male stem of the another adapter intothe respective slots of the housing of the syringe adapter, whereby theseal of the another adapter abuts the seal of the syringe adapter;advancing the male stem of the another adapter into the open distal endof the housing such that the guide pins enter into the respectivehelical track of the collar to rotate the collar relative to the housingof the syringe and align the ribs of the housing with a through portionof the collar; and further advancing the male stem of the anotheradapter into the open distal end of the housing causes the collar tomove proximally which causes the shuttle to move proximally until thetip of the needle penetrates through the abutting seals, whereby thesyringe adapter is in the open state and fluidly interconnects thesyringe with the another adapter.

Each seal may be made from polyisoprene.

The another adapter may be a vial adapter configured to fluidlyinterconnect the syringe adapter to the vial. The vial adapter includesa base defining an opening having a plurality of retainers extendingaround the opening of the base and being configured to snap-fit connectto a neck of the vial, the base defining a lower inner annular rim andan outer annular rim and a cavity therebetween; a cover supported on theouter rim of the base, wherein an expansion chamber is defined withinthe cover and the base; and an adapter support situated within thecavity of the base. The adapter support includes an annular flange forseating on the lower inner annular rim of the base and forming a fluidtight seal therebetween; an annular wall extending from the annularflange and defining an upper inner annular rim, wherein the cover isalso supported on the upper inner annular rim; the male stem extendingin a first direction from the annular flange; and a spike extending in asecond direction from the annular flange, wherein the spike extends intothe opening of the base, wherein the spike includes a first lumen beingin fluid communication with the lumen of the male stem, and wherein thespike includes a second lumen being in fluid communication with theexpansion chamber. The vial adapter further includes a bladder extendingbetween the inner upper annular rim and the outer annular rim of thebase.

The syringe adapter may be movable from the closed state to the openstate by inserting the guide pins of the male stem of the vial adapterinto the respective slots of the housing of the syringe adapter, wherebythe seal of the vial adapter abuts the seal of the syringe adapter;advancing the male stem of the vial adapter into the open distal end ofthe housing such that the guide pins enter into the respective helicaltrack of the collar to (1) rotate the collar relative to the housing ofthe syringe adapter and (2) align the ribs of the housing with a throughportion of the collar; and further advancing the male stem of the vialadapter into the open distal end of the housing causing the collar tomove proximally which causes the shuttle to move proximally until thetip of the needle penetrates through the abutting seals, whereby thesyringe adapter is in the open state and fluidly interconnects thesyringe with the vial adapter.

The spike of the vial adapter may penetrate a septum of the vial upon aconnection of the base of the vial adapter to a neck of the vial.

When the syringe is connected to the syringe adapter, and when thesyringe adapter is connected to the vial adapter, and when the vialadapter is connected to the vial, the syringe is in closed fluidcommunication with the vial.

When the syringe is connected to the syringe adapter, and when thesyringe adapter is connected to the vial adapter, the tip of the needleof the syringe adapter penetrates the abutting seals of the syringeadapter and the vial adapter and when the vial adapter is connected tothe vial, the syringe is in closed fluid communication with the vial.

In use, air from the syringe may be injectable into a cavity of the vialadapter defined between the bladder, and the base and the adaptersupport, through a fluid passage defined by the needle of the syringeadapter, the lumen of the male stem, the first lumen of the spike, thevial and the second lumen of the spike.

The another adapter may be a patient push adapter configured to fluidlyinterconnect the syringe adapter to the I.V. set. The patient pushadapter includes a body portion having a the male stem disposed at afirst end thereof and a patient push adapter luer connector at a secondend thereof, wherein the patient push adapter luer connector is in fluidcommunication with the lumen of the male stem.

The syringe adapter is movable from the closed state to the open stateby inserting the guide pins of the male stem of the patient push adapterinto the respective slots of the housing of the syringe adapter, wherebythe seal of the patient push adapter abuts the seal of the syringeadapter; advancing the male stem of the patient push adapter into theopen distal end of the housing such that the guide pins enter into therespective helical track of the collar to rotate the collar relative tothe housing of the syringe and align the ribs of the housing with athrough portion of the collar; and further advancing the male stem ofthe patient push adapter into the open distal end of the housing causingthe collar to move proximally which causes the shuttle to moveproximally until the tip of the needle penetrates through the abuttingseals, whereby the syringe adapter is in the open state and fluidlyinterconnects the syringe with the I.V. set.

When the syringe is connected to the syringe adapter, and when thesyringe adapter is connected to the patient push adapter, the tip of theneedle of the syringe adapter penetrates the abutting seals of thesyringe adapter and the patient push adapter and when the patient pushadapter is connected to the I.V. set, the syringe is in closed fluidcommunication with the I.V. set.

The another adapter may be an I.V. bag adapter configured to fluidlyinterconnect the syringe adapter to the I.V. bag. The I.V. bag adapterincludes a body portion having a the male stem extending therefrom; aspike extending from a first end of the body portion, the spike defininga first lumen and a second lumen extending therethrough, wherein thefirst lumen of the spike is in fluid communication with the lumen of themale stem; an I.V. bag adapter luer connector disposed at a second endof the body portion and being in fluid communication with the secondlumen of the spike.

The syringe adapter may be movable from the closed state to the openstate by inserting the guide pins of the male stem of the I.V. bagadapter into the respective slots of the housing of the syringe adapter,whereby the seal of the I.V. bag adapter abuts the seal of the syringeadapter; advancing the male stem of the I.V. bag adapter into the opendistal end of the housing such that the guide pins enter into therespective helical track of the collar to rotate the collar relative tothe housing of the syringe and align the ribs of the housing with athrough portion of the collar; and further advancing the male stem ofthe I.V. bag adapter into the open distal end of the housing causing thecollar to move proximally which causes the shuttle to move proximallyuntil the tip of the needle penetrates through the abutting seals,whereby the syringe adapter is in the open state and fluidlyinterconnects the syringe with the I.V. bag.

When the syringe is connected to the syringe adapter, and when thesyringe adapter is connected to the I.V. bag adapter, the tip of theneedle of the syringe adapter penetrates the abutting seals of thesyringe adapter and the I.V. bag adapter and when the I.V. bag adapteris connected to the I.V. bag, the syringe is in closed fluidcommunication with the I.V. bag.

The syringe adapter may include a lock out system having a collarincluding at least one lock arm extending in a radial direction aboutthe collar, wherein each lock arm includes a first end integral with thecollar and a second free end defining a tooth extending radially outwardand being dimensioned to contact a longitudinally extending rib of thehousing; and a shuttle including a relatively larger diameter proximalportion and a relatively smaller diameter distal portion. When theshuttle is in the distal-most position, each lock arm is in registrationwith the relatively larger diameter portion of the shuttle therebyinhibiting each lock arm from deflecting radially inward. When theshuttle is moved proximally, the relatively smaller diameter portion ofthe shuttle is moved into registration with each lock arm therebypermitting each lock arm to deflect radially inward and to permit thecollar to rotate.

According to another aspect of the present disclosure, a closed fluidtransfer system for fluidly interconnecting a syringe to any one of apatient I.V. set, a vial and an I.V. bag. The closed fluid transfersystem comprises a first adapter defining a first adapter lumenextending therethrough, the first adapter supporting a first adapterseal extending across a first end of the first adapter lumen and a firstadapter luer connector at a second end of the first adapter lumen forselectively connecting the first adapter to the syringe, the firstadapter supporting a rear end of a needle within the first adapterlumen, wherein the first adapter seal is movable relative to a tip ofthe needle such that the tip of the needle penetrates through the firstadapter seal.

The closed fluid transfer system further comprises at least one secondadapter for fluidly interconnecting the first adapter to one of thepatient I.V. set, the vial and the I.V. bag, the at least one secondadapter defining a second adapter lumen extending therethrough, the atleast one second adapter supporting a second adapter seal extendingacross a first end of the second adapter lumen and a connector at asecond end of the second adapter lumen for selectively connecting thesecond adapter to one of the patient I.V. set, the vial and the I.V.bag.

When the at least one second adapter is coupled to the first adapter,the second adapter seal abuts the first adapter seal and moves the firstadapter seal relative to the tip of the needle such that the tip of theneedle penetrates through the abutting first adapter seal and secondadapter seal.

The first adapter may include a housing defining an open distal end andan open proximal end, the housing defining a pair of opposedlongitudinally extending slots opening from the open distal end of thehousing, the housing including a pair of opposed longitudinallyextending ribs projecting from an inner surface thereof; a basesupported in the open proximal end of the housing and including thefirst adapter luer connector; a collar slidably and rotatably supportedin the housing, the collar defining a longitudinal opening therethrough,the collar defining a pair of opposed L-shaped tracks formed in an outersurface thereof and configured to receive a respective longitudinallyextending rib therein, the collar defines a pair of opposed helicaltracks opening from a distal surface of the collar, the opposed helicaltracks being aligned with a respective slot of the housing when thecollar is in a distal-most position; a shuttle slidably extendingthrough longitudinal opening of the collar, the shuttle defining ashuttle lumen extending longitudinally therethrough; a barrel supportedon and extending over a distal end of the shuttle, the barrel defining acentral opening aligned with the shuttle lumen; and a biasing memberinterposed between the collar and the shuttle for urging the collar awayfrom the shuttle.

The first adapter seal may be interposed between the shuttle and thebarrel, wherein the first adapter seal extends across the shuttle lumenand the central opening of the barrel. The tip of the needle may bedisposed within the shuttle lumen when the shuttle is in a distal-mostposition.

The at least one second adapter may include a second adapter male stemfor selectively connecting to and insertion into the open distal end ofthe first adapter, the second adapter male stem defining the secondadapter lumen; a pair of opposed guide pins extending radially outwardfrom the male stem; and a pair of opposed guide surfaces extendingradially outward from the male stem at a location proximal of the guidepins and being in registration with the guide pins.

The second adapter seal may extend across the second adapter lumen.

The first adapter may be movable from a closed state to an open state.In the closed state the tip of the needle is disposed within the shuttlelumen, the shuttle is disposed at the distal-most position, and thecollar is disposed at a distal-most position. The first adapter ismovable from the closed state to the open state by inserting the guidepins of the second adapter male stem into the respective slots of thehousing of the first adapter, whereby the second adapter seal of thesecond adapter abuts the first adapter seal of the first adapter;advancing the second adapter male stem into the open distal end of thehousing such that the guide pins of the second adapter enter into therespective helical track of the collar to (1) rotate the collar relativeto the housing of the first adapter and (2) align the ribs of thehousing with a through portion of the collar; and further advancing thesecond adapter male stem into the open distal end of the housing causingthe collar to move proximally which causes the shuttle to moveproximally until the tip of the needle penetrates through the abuttingseals, whereby the first adapter is in the open state and fluidlyinterconnects the syringe with the second adapter.

The at least one second adapter may include a third adapter. The thirdadapter includes a base defining an opening having a plurality ofretainers extending around the opening of the base and being configuredto snap-fit connect to a neck of the vial, the base defining a lowerinner annular rim and an outer annular rim and a cavity therebetween; acover supported on the outer rim of the base, wherein an expansionchamber is defined within the cover and the base; and an adapter supportsituated within the cavity of the base. The adapter support includes anannular flange for seating on the lower inner annular rim of the baseand forming a fluid tight seal therebetween; an annular wall extendingfrom the annular flange and defining an upper inner annular rim, whereinthe cover is also supported on the upper inner annular rim; a thirdadapter male stem for selectively connecting to and insertion into theopen distal end of the first adapter, the third adapter male stemdefining a third adapter lumen, the third adapter male stem extending ina first direction from the annular flange; a pair of opposed guide pinsextending radially outward from the third adapter male stem; and a pairof opposed guide surfaces extending radially outward from the thirdadapter male stem at a location proximal of the guide pins and being inregistration with the guide pins; a third adapter seal extending acrossthe third adapter lumen; and a spike extending in a second directionfrom the annular flange, wherein the spike extends into the opening ofthe base, wherein the spike includes a first spike lumen being in fluidcommunication with the lumen of the male stem of the third adapter, andwherein the spike includes a second spike lumen being in fluidcommunication with the expansion chamber. The third adapter furtherincludes a bladder extending between the inner upper annular rim and theouter annular rim of the base.

The first adapter is movable from the closed state to the open state byinserting the guide pins of the third adapter male stem into therespective slots of the housing of the first adapter, whereby the thirdadapter seal of the third adapter abuts the first adapter seal of thefirst adapter; advancing the third adapter male stem into the opendistal end of the housing such that the guide pins of the third adapterenter into the respective helical track of the collar to (1) rotate thecollar relative to the housing of the first adapter and (2) align theribs of the housing with a through portion of the collar; and furtheradvancing the third adapter male stem into the open distal end of thehousing causing the collar to move proximally which causes the shuttleto move proximally until the tip of the needle penetrates through theabutting seals, whereby the first adapter is in the open state andfluidly interconnects the syringe with the third adapter.

The spike of the third adapter penetrates a septum of the vial upon aconnection of the base of the third adapter to a neck of the vial.

When the syringe is connected to the first adapter, and when the firstadapter is connected to the third adapter, and when the third adapter isconnected to the vial, the syringe is in closed fluid communication withthe vial.

When the syringe is connected to the first adapter, and when the firstadapter is connected to the third adapter, the tip of the needle of thefirst adapter penetrates the abutting seals of the first adapter and thethird adapter and when the third adapter is connected to the vial, thesyringe is in closed fluid communication with the vial.

The at least one second adapter includes a fourth adapter configured tofluidly interconnect the first adapter to the I.V. bag. The fourthadapter includes a body portion having a fourth adapter male stemdisposed at a first end thereof and a fourth adapter luer connectorextending therefrom; a pair of opposed guide pins extending radiallyoutward from the fourth adapter male stem; a pair of opposed guidesurfaces extending radially outward from the fourth adapter male stem ata location proximal of the guide pins and being in registration with theguide pins; a fourth adapter seal extending across the fourth adapterlumen; a spike extending from a second end of the body portion, thespike defining a first lumen and a second lumen extending therethrough.

The first lumen of the spike is in fluid communication with a lumen ofthe fourth adapter male stem, and the second lumen of the spike is influid communication with a lumen of the fourth adapter luer.

The first adapter is movable from the closed state to the open state byinserting the guide pins of the fourth adapter male stem into therespective slots of the housing of the first adapter, whereby the fourthadapter seal adapter abuts the first adapter seal; advancing the fourthadapter male stem into the open distal end of the housing such that theguide pins of the fourth adapter enter into the respective helical trackof the collar to (1) rotate the collar relative to the housing of thefirst adapter and (2) align the ribs of the housing with a throughportion of the collar; and further advancing the fourth adapter malestem into the open distal end of the housing causing the collar to moveproximally which causes the shuttle to move proximally until the tip ofthe needle penetrates through the abutting seals, whereby the firstadapter is in the open state and fluidly interconnects the syringe withthe fourth adapter.

When the syringe is connected to the first adapter, and when the firstadapter is connected to the second adapter, the tip of the needle of thefirst adapter penetrates the abutting seals of the first adapter and thesecond adapter and when the second adapter is connected to the I.V. bag,the syringe is in closed fluid communication with the I.V. bag.

The first adapter includes a lock out system having a collar includingat least one lock arm extending in a radial direction about the collar,wherein each lock arm includes a first end integral with the collar anda second free end defining a tooth extending radially outward and beingdimensioned to contact a longitudinally extending rib of the housing;and a shuttle including a relatively larger diameter proximal portionand a relatively smaller diameter distal portion.

When the shuttle is in the distal-most position, each lock arm is inregistration with the relatively larger diameter portion of the shuttlethereby inhibiting each lock arm from deflecting radially inward. Whenthe shuttle is moved proximally, the relatively smaller diameter portionof the shuttle is moved into registration with each lock arm therebypermitting each lock arm to deflect radially inward and to permit thecollar to rotate.

According to yet another aspect of the present disclosure, a syringeadapter for a closed fluid transfer system is provided. The syringeadapter includes a housing defining an open distal end and an openproximal end, the housing defining a pair of opposed longitudinallyextending slots opening from the open distal end of the housing, thehousing including a pair of opposed longitudinally extending ribsprojecting from an inner surface thereof; a base supported in the openproximal end of the housing and including the syringe adapter luerconnector; a collar slidably and rotatably supported in the housing, thecollar defining a longitudinal opening therethrough, the collar defininga pair of opposed L-shaped tracks formed in an outer surface thereof andconfigured to receive a respective longitudinally extending rib therein,the collar defines a pair of opposed helical tracks opening from adistal surface of the collar, the opposed helical tracks being alignedwith a respective slot of the housing when the collar is in adistal-most position; a shuttle slidably extending through longitudinalopening of the collar, the shuttle defining a shuttle lumen extendinglongitudinally therethrough; a barrel supported on and extending over adistal end of the shuttle, the barrel defining a central opening alignedwith the shuttle lumen; and a biasing member interposed between thecollar and the shuttle for urging the collar away from the shuttle.

The syringe adapter seal is interposed between the shuttle and thebarrel, wherein the syringe first adapter seal extends across theshuttle lumen and the central opening of the barrel. The tip of theneedle is disposed within the shuttle lumen when the shuttle is in adistal-most position.

The syringe adapter may be movable from a closed state to an open state;wherein in the closed state the tip of the needle is disposed within theshuttle lumen, the shuttle is disposed at the distal-most position, andthe collar is disposed at a distal-most position.

Wherein the syringe adapter is movable from the closed state to the openstate by inserting a pair of opposed radially extending guide pins of amale stem of a second adapter into the respective slots of the housingof the syringe adapter, whereby a second adapter seal of the secondadapter abuts the first adapter seal of the first adapter; advancing thesecond adapter male stem into the open distal end of the housing suchthat the guide pins of the second adapter enter into the respectivehelical track of the collar to (1) rotate the collar relative to thehousing of the syringe adapter and (2) align the ribs of the housingwith a through portion of the collar; and further advancing the secondadapter male stem into the open distal end of the housing causing thecollar to move proximally which causes the shuttle to move proximallyuntil the tip of the needle penetrates through the abutting seals,whereby the syringe adapter is in the open state and fluidlyinterconnects a syringe with the second adapter.

According to still another aspect of the present disclosure, a vialadapter for a closed fluid transfer system is provided. The vial adapterincludes a base defining an opening having a plurality of retainersextending around the opening of the base and being configured tosnap-fit connect to a neck of a vial, the base defining a lower innerannular rim and an outer annular rim and a cavity therebetween; a coversupported on the outer rim of the base, wherein an expansion chamber isdefined within the cover and the base; and an adapter support situatedwithin the cavity of the base. The adapter support includes an annularflange for seating on the lower inner annular rim of the base andforming a fluid tight seal therebetween; an annular wall extending fromthe annular flange and defining an upper inner annular rim, wherein thecover is also supported on the upper inner annular rim; a male stemextending in a first direction from the annular flange; a male stem forselectively connecting to and insertion into a open distal end of asyringe adapter, the male stem defining a lumen extending therethrough;a pair of opposed guide pins extending radially outward from the malestem; a pair of opposed guide surfaces extending radially outward fromthe male stem at a location proximal of the guide pins and being inregistration with the guide pins; a seal extending across the lumen ofthe male stem; and a spike extending in a second direction from theannular flange, wherein the spike extends into the opening of the base,wherein the spike includes a first lumen being in fluid communicationwith the lumen of the male stem, and wherein the spike includes a secondlumen being in fluid communication with the expansion chamber. The vialadapter further includes a bladder extending between the inner upperannular rim and the outer annular rim of the base.

The vial adapter is configured to move a syringe adapter from a closedstate to an open state. The syringe adapter includes a housing definingan open distal end and an open proximal end, the housing defining a pairof opposed longitudinally extending slots opening from the open distalend of the housing, the housing including a pair of opposedlongitudinally extending ribs projecting from an inner surface thereof;a base supported in the open proximal end of the housing and includingthe syringe adapter luer connector; a collar slidably and rotatablysupported in the housing, the collar defining a longitudinal openingtherethrough, the collar defining a pair of opposed L-shaped tracksformed in an outer surface thereof and configured to receive arespective longitudinally extending rib therein, the collar defines apair of opposed helical tracks opening from a distal surface of thecollar, the opposed helical tracks being aligned with a respective slotof the housing when the collar is in a distal-most position; a shuttleslidably extending through longitudinal opening of the collar, theshuttle defining a shuttle lumen extending longitudinally therethrough;a barrel supported on and extending over a distal end of the shuttle,the barrel defining a central opening aligned with the shuttle lumen;and a biasing member interposed between the collar and the shuttle forurging the collar away from the shuttle. The syringe adapter seal isinterposed between the shuttle and the barrel, wherein the syringe firstadapter seal extends across the shuttle lumen and the central opening ofthe barrel. The tip of the needle is disposed within the shuttle lumenwhen the shuttle is in a distal-most position.

In use, the vial adapter moves the syringe adapter from the closed stateto the open state upon inserting the guide pins of the male stem of thevial adapter into the respective slots of the housing of the syringeadapter, whereby the seal of the vial adapter abuts the seal of thesyringe adapter; advancing the male stem of the vial adapter into theopen distal end of the housing such that the guide pins enter into therespective helical track of the collar to (1) rotate the collar relativeto the housing of the syringe adapter and (2) align the ribs of thehousing with a through portion of the collar; and further advancing themale stem of the vial adapter into the open distal end of the housingcausing the collar to move proximally which causes the shuttle to moveproximally until the tip of the needle penetrates through the abuttingseals, whereby the syringe adapter is in the open state and fluidlyinterconnects the syringe with the vial adapter.

According to yet another aspect of the present disclosure, a patientpush adapter for a closed fluid transfer system is provided. The patientpush adapter includes a body portion having a male stem disposed at afirst end thereof and a patient push adapter luer connector at a secondend thereof, wherein the male stem defines a lumen extendingtherethrough and wherein the patient push adapter luer connector is influid communication with the lumen of the male stein; a pair of opposedguide pins extending radially outward from the male stem; a pair ofopposed guide surfaces extending radially outward from the male stem ata location proximal of the guide pins and being in registration with theguide pins; and a seal extending across the lumen of the male stein.

The patient push adapter is configured to move a syringe adapter from aclosed state to an open state. The syringe adapter includes a housingdefining an open distal end and an open proximal end, the housingdefining a pair of opposed longitudinally extending slots opening fromthe open distal end of the housing, the housing including a pair ofopposed longitudinally extending ribs projecting from an inner surfacethereof; a base supported in the open proximal end of the housing andincluding the syringe adapter luer connector; a collar slidably androtatably supported in the housing, the collar defining a longitudinalopening therethrough, the collar defining a pair of opposed L-shapedtracks formed in an outer surface thereof and configured to receive arespective longitudinally extending rib therein, the collar defines apair of opposed helical tracks opening from a distal surface of thecollar, the opposed helical tracks being aligned with a respective slotof the housing when the collar is in a distal-most position; a shuttleslidably extending through longitudinal opening of the collar, theshuttle defining a shuttle lumen extending longitudinally therethrough;a barrel supported on and extending over a distal end of the shuttle,the barrel defining a central opening aligned with the shuttle lumen;and a biasing member interposed between the collar and the shuttle forurging the collar away from the shuttle. The syringe adapter seal isinterposed between the shuttle and the barrel, wherein the syringe firstadapter seal extends across the shuttle lumen and the central opening ofthe barrel. The tip of the needle is disposed within the shuttle lumenwhen the shuttle is in a distal-most position.

In use, the patient push adapter moves the syringe adapter from theclosed state to the open state upon inserting the guide pins of the malestem of the patient push adapter into the respective slots of thehousing of the syringe adapter, whereby the seal of the patient pushadapter abuts the seal of the syringe adapter; advancing the male stemof the patient push adapter into the open distal end of the housing suchthat the guide pins enter into the respective helical track of thecollar to (1) rotate the collar relative to the housing of the syringeadapter and (2) align the ribs of the housing with a through portion ofthe collar; and further advancing the male stem of the patient pushadapter into the open distal end of the housing causing the collar tomove proximally which causes the shuttle to move proximally until thetip of the needle penetrates through the abutting seals, whereby thesyringe adapter is in the open state and fluidly interconnects thesyringe with the patient push adapter.

According to a further aspect of the present disclosure, an I.V. bagadapter for a closed fluid transfer system is provided. The I.V. bagadapter includes a body portion having a the male stem extendingtherefrom; a body portion having a male stem extending from a sidethereof, wherein the male stem defines a lumen extending therethrough; apair of opposed guide pins extending radially outward from the malestem; a pair of opposed guide surfaces extending radially outward fromthe male stem at a location proximal of the guide pins and being inregistration with the guide pins; a seal extending across the lumen ofthe male stem; a spike extending from a first end of the body portion,the spike defining a first lumen and a second lumen extendingtherethrough, wherein the first lumen of the spike is in fluidcommunication with the lumen of the male stem; and an I.V. bag adapterluer connector disposed at a second end of the body portion and being influid communication with the second lumen of the spike.

The I.V. bag adapter is configured to move a syringe adapter from aclosed state to an open state. The syringe adapter includes a housingdefining an open distal end and an open proximal end, the housingdefining a pair of opposed longitudinally extending slots opening fromthe open distal end of the housing, the housing including a pair ofopposed longitudinally extending ribs projecting from an inner surfacethereof; a base supported in the open proximal end of the housing andincluding the syringe adapter luer connector; a collar slidably androtatably supported in the housing, the collar defining a longitudinalopening therethrough, the collar defining a pair of opposed L-shapedtracks formed in an outer surface thereof and configured to receive arespective longitudinally extending rib therein, the collar defines apair of opposed helical tracks opening from a distal surface of thecollar, the opposed helical tracks being aligned with a respective slotof the housing when the collar is in a distal-most position; a shuttleslidably extending through longitudinal opening of the collar, theshuttle defining a shuttle lumen extending longitudinally therethrough;a barrel supported on and extending over a distal end of the shuttle,the barrel defining a central opening aligned with the shuttle lumen;and a biasing member interposed between the collar and the shuttle forurging the collar away from the shuttle. The syringe adapter seal beinginterposed between the shuttle and the barrel, wherein the syringe firstadapter seal extends across the shuttle lumen and the central opening ofthe barrel. The tip of the needle being disposed within the shuttlelumen when the shuttle is in a distal-most position.

In use, the I.V. bag adapter moves the syringe adapter from the closedstate to the open state upon inserting the guide pins of the male stemof the I.V. bag adapter into the respective slots of the housing of thesyringe adapter, whereby the seal of the I.V. bag adapter abuts the sealof the syringe adapter; advancing the male stem of the I.V. bag adapterinto the open distal end of the housing such that the guide pins enterinto the respective helical track of the collar to (1) rotate the collarrelative to the housing of the syringe adapter and (2) align the ribs ofthe housing with a through portion of the collar; and further advancingthe male stem of the I.V. bag adapter into the open distal end of thehousing causing the collar to move proximally which causes the shuttleto move proximally until the tip of the needle penetrates through theabutting seals, whereby the syringe adapter is in the open state andfluidly interconnects the syringe with the I.V. bag adapter.

The invention will be explained in greater detail below in descriptionsof preferred embodiments and referring to the attached figures.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following, the preferred embodiments of invention will bedescribed in detail with reference to the following attached figures:

FIG. 1 is a schematic illustration of a closed fluid transfer system ofthe present disclosure illustrating a fluid connectability of a syringeto an I.V. Set, a vial and an I.V. bag via combination of a syringeadapter and one of an I.V. set adapter, a vial adapter and an I.V. bagadapter;

FIG. 2 is a perspective view of a syringe adapter of the closed fluidtransfer system of FIG. 1;

FIG. 3 is a perspective view, with parts separated, of the syringeadapter of FIG. 2;

FIG. 4 is a longitudinal, cross-sectional view of the syringe adapter ofFIGS. 2 and 3;

FIG. 5 is an enlarged view, of the indicated area of detail of FIG. 2,with the outer side portions shown in phantom;

FIG. 6 is a top, perspective view of a collar of the syringe adapter ofFIGS. 1-5;

FIG. 7 is a longitudinal cross-sectional view of the collar of FIGS. 5and 6;

FIG. 8 is a perspective view of a vial adapter of the closed fluidtransfer system of FIG. 1;

FIG. 9 is a perspective view, with parts separated, of the vial adapterof FIG. 8;

FIG. 10 is a longitudinal, cross-sectional view of the vial adapter ofFIGS. 8 and 9;

FIG. 11 is a top, perspective view of a patient push adapter of theclosed fluid transfer system of FIG. 1;

FIG. 12 is a bottom, perspective view of a patient push adapter of theclosed fluid transfer system of FIG. 1;

FIG. 13, is a perspective view, with parts separated, of the patientpush adapter of FIGS. 11 and 12;

FIG. 14 is a longitudinal, cross-sectional view of the patient pushadapter of FIGS. 11-13;

FIG. 15 is a bottom, perspective view of an I.V. bag adapter of theclosed fluid transfer system of FIG. 1;

FIG. 16 is a longitudinal, cross-sectional view of the I.V. bag adapterof FIG. 15;

FIG. 17 is a distal, perspective view of a syringe adapter, with thehousing removed, according to another embodiment of the presentdisclosure;

FIG. 18 is a side, elevational view of a distal end of the syringeadapter of FIG. 17, with one housing half removed;

FIG. 19 is a further side, elevational view of a distal end of thesyringe adapter of FIG. 17;

FIG. 20 is a longitudinal, cross-sectional view of a distal end of thesyringe adapter of FIGS. 17-19;

FIG. 21 is a further, longitudinal, cross-sectional view of a distal endof the syringe adapter of FIGS. 17-19, illustrating a locking system ofthe syringe adapter in a first condition;

FIG. 22 is a cross-sectional view of the syringe adapter of FIG. 21, astaken through 22-22 of FIG. 21;

FIG. 23 is a further, longitudinal, cross-sectional view of a distal endof the syringe adapter of FIGS. 17-19, illustrating a locking system ofthe syringe adapter in a second condition;

FIG. 24 is a cross-sectional view of the syringe adapter of FIG. 23, astaken through 24-24 of FIG. 22;

FIG. 25 is a schematic, elevational view of a universal vial adapteraccording to an embodiment of the present disclosure, shown connected toa vial neck having a first diameter;

FIG. 26 is a top, plan view of a hub of the universal vial adapter asconnected to the vial of FIG. 25;

FIG. 27 is a perspective view of the hub of the universal vial adapteras connected to the vial of FIG. 25;

FIG. 28 is a schematic, elevational view of the universal vial adapterof FIG. 25, shown connected to a vial neck having a second diameter;

FIG. 29 is a top, plan view of a hub of the universal vial adapter asconnected to the vial of FIG. 28;

FIG. 30 is a perspective view of the hub of the universal vial adapteras connected to the vial of FIG. 28;

FIG. 31 is a schematic, longitudinal, cross-sectional view of theuniversal vial adapter of FIGS. 25-30; and

FIGS. 32-38 illustrate a sequence of fluidly connecting a syringeadapter and a patient push adapter.

DETAILED DESCRIPTION

The closed fluid transfer system, in accordance with the presentdisclosure, is generally designated as 100 and generally includes amodule/adapter that fluidly connects to a syringe or any male luer lockconnection point; a patient push module/adapter that fluidly connectsdirectly to an I.V. line; at least a module/adapter that fluidlyconnects to a vial/container storing/containing a fluid/liquid in theform of a hazardous drug and the like; and a module/adapter that fluidlyconnects to an I.V. bag. Each of the above-mentioned modules/adapterswill be described in greater detail below with reference to theaccompanying figures, wherein like numbers identify like elements.

In accordance with the present disclosure, the system is a “closed”fluid-transfer system capable of transferring liquids between aconventional syringe and one of a patient I.V. set, a vial, or an I.V.bag without leaking or spilling and without exposure of thegases/fluids/liquids or other substances to a location or a substanceoutside the closed system. One purpose of the closed fluid transfersystem is to permit health care personnel to safely use and handleliquid-form medicine, including potentially hazardous liquid drugsand/or the like.

In accordance with the present disclosure, and as will be discussed ingreater detail below, the closed fluid transfer system 100 includes asyringe adapter 11 (see FIGS. 1-7) that is structured to provide aclosed fluid connection between a first fluid container in the form of aconventional needleless syringe “I” and a second fluid container/conduitin the form of a patient I.V. set, a vial “V”, or an I.V. bag. The fluidtransfer is accomplished by first connecting one of a patient pushadapter 15 (see FIGS. 1 and 11-14) to an I.V. set, a vial adapter 13(see FIGS. 1 and 8-10) to a vial, or an I.V. bag adapter 17 (see FIGS. 1and 15-16) to an I.V. bag, as necessary. Each adapter 13, 15, 17 isprovided with an identical male stem 19 which defines an internal lumen21 closed at one end by a resilient seal 23. The syringe adapter 11 ismated to the male stem 19, thereby permitting fluid flow from or to thesyringe “I”, as described in more detail herein.

Referring now specifically to FIGS. 1-7, the closed fluid transfersystem 100 includes a syringe adapter 11. Syringe adapter 11 is a typeof valve which can be in an open state to permit fluid flow therethroughor in a closed state to prevent fluid flow. The open and closed statesoccur in a specific sequence dictated by the syringe adapter 11architecture as described herein.

The syringe adapter 11 consists of four main parts which are a housing25, a conventional hollow metal needle 27, a shuttle 29, and a collar31. The housing 25 is generally cylindrical in shape having a distal end33 and a proximal end 35, a longitudinal axis 37, a distal opening 39,and a female cavity 41 into which the male stem 19 is received. Housing25 may be formed to have two housing side portions or halves 43, 45 anda housing base portion 47 which fits partially between the side portions43, 45. Side portions 43, 45 define opposed slots 49, 51 (see FIGS. 2and 4) which begin at housing distal end 33 and extend within housing25. Slots 49, 51 which receive a respective guide pin 53, 55 and guidesurface 57, 59 of any male stem 19, which are each keyed to a respectiveone of the slots 49, 51 (or a respective one of slots 51, 49), for thepurposes described in full detail below.

Hollow metal needle 27, as seen in FIGS. 3 and 4, is a conventionalneedle with a sharpened tip 61, a tip end opening 63, a proximal endopening 65, and a lumen 67 permitting fluid flow through theconventional needle 27 between the needle openings 63, 65. It isenvisioned that needle 27 will be a conventional 18 gauge steel “penciltip” needle commercially available (18 gauge refers to the outerdiameter of needle 27). The conventional pencil tip needle 27 has anextremely sharp tip 61 with opening 63 spaced slightly away from thesharpened tip 61. The pencil tip needle 27 is of a type and sizeconventionally used with syringes to penetrate patient blood vessels fordelivery or extraction of fluids.

Needle 27 is mounted within housing 25, in fixed-positionalrelationship, on an inner side of base 47 with tip 61 of needle 27pointing/extending toward distal end 33 of housing 25. An advantage ofthis design is that needle 27, and specifically, the extremely sharpneedle tip 61 of needle 27, are fully enclosed within the housing 25 andare completely shielded from contact with a user. In this manner, thepossibility of injuries as a result of user needle-stick, has beensignificantly reduced and/or eliminated.

Housing base 47 is rotatably supported in housing 25. Housing base 47includes an outer side with a conventional luer connector 69 provided toaccept the delivery end of a conventional needless syringe. A lumen 71extends through base 47 between luer connector 69 and proximal opening65 of needle 27 permitting fluid flow between the needle tip opening 63and the luer connector 69.

Housing 25 and housing base 47 of syringe adapter 11 cooperate with oneanother to provide a ratchet mechanism by which syringe adapter 11 maynot be accidentally or inadvertently disconnected from syringe “I”. Inparticular, the ratchet mechanism includes, as seen in FIG. 3, aplurality of ribs 25 a formed on an inner surface of housing 25 and atleast one resilient finger 47 a supported on housing base 47, wherebyhousing base 47 is held in a fixed position relative to housing 25 whensyringe adapter 11 is connected to syringe 11 and to is free to rotaterelative to housing 25 if syringe adapter 11 is being inadvertently oraccidently disconnected from syringe “I”. In this manner, the closedsystem between the syringe adapter 11 and syringe 11 is bettermaintained.

Generally, in operation, when syringe adapter 11 is connected to syringe“I”, the at least one resilient finger 47 a of housing base 47 engagesribs 25 a of housing in such a manner that rotation of housing base 47relative to housing 25 is inhibited and syringe adapter 11 may besecurely connected to syringe “I”. Further, if there is an inadvertentor accidental rotation of syringe adapter 11 relative to syringe “I”,tending to disconnect syringe adapter 11 from syringe and thus destroythe closed system, each resilient finger 47 a is configured to slip overand across ribs 25 a of housing 25, allowing housing base 47 to rotaterelative to housing 25 and thus maintain the closed system.

If it is desired to intentionally disconnect syringe “I” from syringeadapter 11, a user may squeeze housing 25 radially inward, in theproximity of luer connector 69, to engage at least one tooth (not shown)formed on an inner surface of housing 25 with a respective notch 47 bformed in an outer surface of housing base 47. Then, with the at leastone tooth (not shown) of housing 25 engaged with the respective notch 47b of housing base 47, the user may rotate syringe adapter 11 relative tosyringe “I” to disconnect syringe “I” from luer connector 69 of housingbase 47.

Shuttle 29 is provided for at least the following important purposes.First, shuttle 29 supports shuttle distal seal 73 across distal opening39 of housing 25 to close cavity 41 of housing 25 so that contaminantscannot enter the housing 25 when the syringe adapter 11 is not mated toone of the adapters 13, 15, 17. Second, the shuttle 29 supports shuttledistal seal 73 at a position across distal opening 39 of housing 25 sothat distal seal 73 can be easily swabbed with alcohol before use toensure that the seal 73 is sterile. In accordance with the presentdisclosure, and as is customary, a seal 23 of any male stem 19 (as seenin for example FIG. 8 and as will be described in greater detail below)is also swabbed with alcohol or other microbial agent before being matedto the syringe adapter 11, so as to ensure sterility of the abutmentbetween seals 23 and 73. Finally, the shuttle 29 provides a fluid-tightenclosure for needle 27 to prevent fluid flow outside of syringe adapter11 when in the closed state.

As illustrated in FIGS. 3 and 4, shuttle 29 includes distal and proximalannular flanges 75, 77, respectively, and an intermediate body portion79 between flanges 75, 77 defining a shuttle lumen 81 therethrough.Distal flange 75 supports a distal seal 73 and a barrel 83, seated ondistal flange 75, holds distal seal 73 on distal flange 75. Shuttleproximal flange 77 supports a proximal seal 85.

As illustrated in FIGS. 3 and 4, tip 61 of needle 27 extends intoshuttle lumen 81 and proximal seal 85 forms a fluid-tight seal aroundneedle 27. In the closed state, when syringe adapter 11 is fluidlyconnected to syringe “I”, needle tip 61 and opening 63 are withinshuttle lumen 81 and seals 73, 85 prevent fluid from exiting shuttlelumen 81.

Each seal 23, 73 is generally disk shaped and includes a respectiveoutward projection 87, 89 (i.e., convex surface) which abut one anotherwhen the seals 23, 73 are held together, as described later herein.Seals 23, 73 and 85 are made of polyisoprene and seals 23 and 73 aredesigned want to retain or return to their original convex profile whenin abutment with one another. Put another way, since seals 23, 73 arefabricated from a resilient material and tend to want to retain orreturn to their original convex profile, when seals 23, 73 are inabutment with one another, a substantially continuous interface betweenseals 23, 73 is established and maintained. While it is preferred thatseals 23 and 73 be made from polyisoprene, it is contemplated and withinthe scope of the present disclosure, that seals 23, 73 may be made fromthermoplastic elastomers (TPE), silicone, more specifically,HaloButyl-Polyisoprene, Chlorobutyl, thermoplastic vulcanizates (TPVs),any other resilient polymer, or any combinations thereof.

Intermediate portion 79 of shuttle 29 rides in collar opening 91 incollar end wall 93 of collar 31 for axial movement along axis 37 withinhousing 25. Barrel 83 is generally cylindrical in shape and has anoutside diameter slightly less than an inside diameter of collar 31 topermit barrel 83 and shuttle 29 to reciprocate inside collar 31.

A spring 95 is provided and bears against end wall 93 of collar 31 anddistal flange 75, partially within barrel 83. Spring 95 biases shuttle29 toward distal end 33 of housing 25 so that distal seal 73 of shuttle29 covers or extends across opening 39 of housing 25, for the reasonspreviously described. Spring-biased contact between barrel 83 and endwall 93 of collar 31 limits inward movement of shuttle 29 towardproximal end 35 of housing 25, and contact between proximal flange 77 ofshuttle 29 and end wall 93 of collar 31 limits outward movement ofshuttle 29 toward distal end 33 of housing 25.

Distal seal 73 of shuttle 29 does not contact the housing 25 and issupported solely by shuttle 29 and travels within collar 31 spaced fromhousing 25. Shuttle 29 is pushed axially toward proximal end 35 ofhousing 25 when contacted by seal 23 of any male stem 19 during use, asdescribed more fully below.

With continued reference to FIGS. 2-7, collar 31 and housing 25cooperate to hold male stem 19 and seal 23 (for example, as seen in FIG.8) thereof in abutment with distal seal 73 of shuttle 29 so that theabutting seals 23, 73 can subsequently be pierced by needle tip 61 ofneedle 27 and so that needle 27 can enter lumen 21 of male stem 19 toopen the fluid path through syringe adapter 11. The abutment betweenseals 23, 73 established that distal seal 73 of shuttle 29 is theclosure for distal opening 39 of housing 25 and also places distal seal73 of shuttle 29 in a position convenient for swabbing with alcoholbefore use. The abutment between seals 23, 73 ensures that the two seals23, 73 function as one and can be pierced together by needle 27. If theseals 23, 73 were to separate with needle tip opening 63 extendedoutside of lumen 81 of shuttle 29, liquids could leak into cavity 41 ofhousing 25, which is contrary to the purpose of providing a closedsystem.

Referring now to FIGS. 3-7, collar 31 is generally cylindrical in shapecorresponding to the shape of cavity 41 of housing 25. Collar 31includes a proximal end wall 93 and a side wall 97 extending fromproximal wall 93. Side wall 97 of collar 31 includes two opposedexaggerated angled L-shaped tracks 99 formed in an outer surfacethereof, one of which can be seen in FIGS. 6 and 7. The other L-shapedtrack is not shown but is a mirror image of L-shaped track 99 shown. Forsimplicity, reference numeral 99 will refer to both L-shaped tracks. Asseen in FIG. 6, each track 99 has a lower portion 101 defined by anupper stop wall or shoulder 103 and first and second lateral,longitudinally extending side walls 105, 107. Each track 99 further hasa through portion 109 defined by second side wall 107 and a third sidewall 111 which is on an end of upper stop wall 103.

On the inside surface of housing 25, facing collar 31 and projectinginto each of the two L-shaped tracks 99, are two opposed longitudinallyextending male ribs 113, one of which 113 can be seen in FIG. 5. Theother rib is not visible but is a mirror image of visible rib 113. Forsimplicity reference number 113 will refer to both ribs. Each of the tworibs 113 is parallel relative to axis 37. Each rib 113 has a width whichis slightly less than the gap between the second side wall 107 and thethird side wall 111 defining the through portion 109.

In operation, each rib 113 cooperates with a respective L-shaped track99 in an identical manner to permit limited rotational and axialmovement of collar 31, as described herein. Specifically, contactbetween each rib 113 and respective first side wall 105 and second sidewall 107, with respective upper stop wall 103 riding along rib 113,limits the rotational movement of collar 31 to about 6°, while collar 31is constrained to move axially along axis 37. In this position, collar31 supports distal seal 73 of shuttle 29 across opening 39 of housing25.

After approximately 6° of rotational movement of collar 31, each rib 113enters respective through portions 109 of L-shaped tracks 99, whereincontact between each rib 113 and respective second side wall and thirdside wall 107, 111 permits collar 31 to move axially along axis 37, butconstrains collar 31 from further rotational movement. With each rib 113in respective through portions 109, collar 31 can move axially alongaxis 37 toward proximal end 35 of housing 25 so that tip 61 of needle 27can pierce abutting seals 23, 73 to place the syringe adapter 11 in anopen state. Alternatively, collar 31 can move axially toward distal end33 of housing 25 so that tip 61 of needle 27 exits seals 23, 73 andre-enters lumen 81 of shuttle 29 to place syringe adapter 11 in theclosed state.

Side wall 97 of collar 31 further includes helical tracks 115, 117formed in an outer surface thereof. Guide pins 53, 55 of any male stem19 are received in a respective helical track 115 or 117 for purposes ofrotating collar 31 and holding seals 23, 73 in abutment with oneanother, as will now be described.

With reference to FIGS. 32-38, syringe adapter 11 (or syringe adapter611, see FIGS. 17-24) operates in substantially a two-step manner.Initially, a male stem 19 supporting a seal 23, such as in the vialadapter 13 (not shown), the patient push adapter 15 (as shown in FIGS.32-38) or the I.V. bag adapter 17 (not shown), is held in abutment withdistal seal 73 of shuttle 29. Then, the held-together or abutting seals23, 73 are pierced with the tip 61 of needle 27 so that needle 27 canenter the lumen 21 of male stem 19 to open the fluid path throughsyringe adapter 11, thereby placing syringe adapter 11 in the open stateand in fluid communication with the vial adapter 13, the patient pushadapter 15 or the I.V. bag adapter 17.

More specifically, in the initial step, as seen in FIGS. 32-34,diametrically opposed, radially extending guide pins 53, 55 of male stem19 (of, for example, patient push adapter 15) and diametrically opposed,radially extending guide surfaces 57, 59 of male stem 19 are firstinserted into respective slots 49, 51 of housing 25 with stem seal 23 ofmale stem 19 in abutment with distal seal 73 of shuttle 29. Next, stemseal 23 of male stem 19 enters cavity 41 (see FIGS. 4, 38) of housing 25and guide pins 53, 55 of male stem 19 enter a respective helical track115, 117 (or 715, 717) of collar 31 (or 631). Simultaneously, shuttle 29moves axially along axis 37 toward end wall 93 of collar 31 (or 631) andproximal end 35 of housing 25, against spring 95 because collar 31 (or631) is axially constrained by contact between each rib 113 (or 713) anda respective upper stop or side wall 103 of collar 31 (or 631). Due tothe axial constraint imposed on collar 31 (or 631) by each rib 113 (or713) and respective upper side walls 103, shuttle 29 will move axiallytoward proximal end 35 of housing 25 until barrel 83 of shuttle 29bottoms out against end wall 93 of collar 31 (or 631).

Axial movement of guide pins 53, 55 of male stem 19, within a respectivecollar helical track 115, 117 (or 715, 717), while collar 31 (or 631) isaxially constrained, causes collar 31 (or 631) to rotate(counterclockwise as illustrated in the FIGS. 36 and 37) and each of thetwo upper side walls 103 of collar 31 (or 631) to slide along arespective rib 113 (or 713). As mentioned above, this rotation of collar31 (or 631) is limited to about 6° by contact between ribs 113 (or 713)and a respective second side wall 107. Male stem 19 is unable to rotateas male stem 19 is inserted into syringe adapter 11 (or 611) becauseguide surfaces 57, 59 of male stem 19 are constrained within slots 49and 51 of housing 25.

The restraint on further rotation of collar 31 (or 631), provided bycontact between the ribs 113 (or 713) and the respective second sidewalls 107, in turn, limits further axial movement of male stem 19because the guide pins 53, 55 of male stem 19 are now axiallyconstrained by the helical tracks 115, 117 (or 715, 717) of collar 31(or 631). When shuttle 29 is bottomed out against end wall 93 of collar31 (or 631), further axial movement of shuttle 29 relative to collar 31(or 631) is prevented. The result is that seal 23 of male stem 19 isheld in abutment against distal end seal 73 of shuttle 29. Tip 61 ofneedle 27 remains axially spaced from abutting seals 23, 73 and there isno fluid flow through syringe adapter 11 (or 611).

In the following step, as seen in FIG. 38, the user pushes male stem 19and abutting seals 23, 73 further into cavity 41 of housing 25 (seeFIGS. 4, 38) of syringe adapter 11 (or 611). Further axial movement ofshuttle 29 and collar 31 is possible now because collar 31 has beenrotated so that through portion 109 of each collar L-shaped track 99(see FIGS. 5-7) is in alignment with a rib 113 (or 713), wherein ribs113 (or 713) are between second and third side walls 107, 111 (see FIGS.5-7). Further movement of male stem 19 into cavity 41 (see FIG. 4) movescollar 31 (or 631) and abutting seals 23, 73 toward tip 61 of needle 27causing tip 61 of needle 27 to pierce the abutting seals 23, 73 andfurther causing needle 27 to enter lumen 21 of male stem 19 to open thefluid path through syringe adapter 11 (or 611), thereby placing syringeadapter 11 (or 611) in the open state and in fluid communication withthe vial adapter 13 (not shown), the patient push adapter 15 or the I.V.bag adapter 17 (not shown). Fluids can now flow from needle 27 towardthe vial adapter 13, the patient push adapter 15 or the I.V. bag adapter17, or can flow in a reverse direction.

To remove the male stem 19 of the vial adapter 13 (not shown), thepatient push adapter 15 or the I.V. bag adapter 17 (not shown) fromsyringe adapter 11 (or 611), the adapter 13, 15, or 17 is pulled fullyaway from the distal end 33 of housing 25. The process described abovetakes place in reverse, thereby stopping a flow of fluid once needle tip61 is fully retracted within lumen 81 of shuttle 29 (sec FIG. 4),thereby placing the syringe adapter 11 (or 611) into the closed state.

In accordance with the present disclosure, as seen in FIGS. 2-5, it isfurther contemplated that distal end 33 of housing 25 of syringe adapter11 may have a substantially sinusoidal distal profile or distal endsurface 33 a (see FIG. 2), wherein opposed slots 49, 51 of syringeadapter 11 are disposed at a respective opposed nadir or low point ofdistal end surface 33 a. Meanwhile, as seen in FIGS. 11-13, body 301 ofpatient push adapter 15 may include a substantially sinusoidal profileor surface 301 a extending therearound, wherein opposed guide surfaces55, 57 of patient push adapter 15 are disposed and a respective opposedapex or high point of surface 301 a. It is contemplated that distal endsurface 33 a of syringe adapter 11 and surface 301 a of patient pushadapter 15 substantially complement one another.

Turning now to FIGS. 1 and 8-10, vial adapter 13 of the closed fluidtransfer system 100 of the present disclosure, will be discussed ingreater detail. Generally, vial adapter 13 connects to a neck “N” of avial, bottle, or other container “V” holding liquid “L” to be extractedor into which liquid is to be delivered. For convenience, thesecontainers will be referred to collectively by the term “vial.” Vialadapter 13 may be provided in sizes and configurations as necessary toattach to commercially-available vials.

As illustrated in FIGS. 8-10, vial adapter 13 includes a base 201, anadapter support 203 (including a male stem 19 supporting a seal 23 andincluding guide pins 53, 55, as described above), a spike 205, and anexpansion chamber 207. Vial adapter 13 includes distal and proximal ends209, 211.

As best shown in FIGS. 9 and 10, base 201 is substantially bowl-shapedand is configured to receive and/or seat an adapter support 203 thereon.Vial adapter 13 includes a toroid-shaped expansion chamber 207,including a bladder 227 and translucent cover 215, seated on an innerrim and an outer rim of base 201. Bladder 227 having a substantiallyU-shaped radial cross-section including a first annular rim capturedbetween the outer annular rim of base 201 and the outer annular rim ofcover 215, and a second annular rim captured between the inner annularrim of base 201 and the inner annular rim of cover 215.

Base 201 of vial adapter 13 includes a circular opening 217 alongproximal end 211 thereof into which neck “N” of vial “V” is received.Retainers 219 are provided around the circumference of opening 217 toconnect base 201 of vial adapter 13 to form a permanent connection oncethe neck “N” of the vial “V” is inserted into opening 217.

As seen in FIG. 10, spike 205 extends away from proximal end 211 of base201 and includes a tip 221 configured to pierce a septum “S” provided onvial “V” when the neck “N” of the vial “V” is inserted into opening 217of base 201. Spike 205 has a length sufficient to extend into the vial“V”. Spike 205 is preferably made of plastic, however, it is envisionedthat spike 205 may preferably support a metallic piercing member orhypo-tube 205 a to assist in the ability of spike 205 to penetrate theseptum “S” of the vial “V”.

As seen in FIG. 10, spike 205 and adapter support 203 define two ducts223, 225. A first duct 223 extends between tip 221 of spike 205 andlumen 21 of male stem 19, and is provided to permit fluid flow betweenthe vial “V” and male stem 19. As described above, opening 63 of tip 61of needle 27 extends into lumen 21 to extract or deliver liquid throughduct 223 when syringe adapter 11 is in the open state. A second duct 225extends between tip 221 of spike 205 and a first cavity 207 a of chamber207 defined within expansion chamber 207 when toroid-shaped bladder 227is deflated. Chamber 207 a of expansion chamber 207 expands upon amovement of bladder 227 when air or other gas is injected into male stem19 and duct 223 from a syringe “1” that is attached to syringe adapter11.

In operation, vial adapter 13 is initially connected to neck “N” of vial“V” with spike 205 piercing septum “S” of vial “V” such that ducts 223,225 of spike 205 extend into the vial “V”. Syringe adapter 11 (as shownand described above) is then attached to male stem 19 of vial adapter13, as described previously. Liquid “L” may then be extracted from ordelivered to the vial “V”. If the user wishes to first charge thesyringe “1” with air or other gas, then the air may be transferredthrough the ducts 223, 225 of spike 205 of vial adapter 13 and intofirst cavity 207 a of chamber 207, wherein bladder 227 is moved toaccommodate the air. Air in first cavity 207 a of chamber 207 moves backinto the vial “V” as liquid “L” is withdrawn from the vial “V” and intothe syringe “I”.

The vial “V” and vial adapter 13 are discarded once the liquid “L” isremoved from the vial “V”.

It is contemplated and understood that proximal end 211 of base 201 maybe sized to accommodate different size necks of different size vials,such as, for example, a 20 mm vial cap of a 60 ml vial; a 28 mm vial capof a 60 ml vial; and a 13 mm vial cap of a 20 ml vial. Accordingly, adiameter of proximal end of base 201 of vial adapter 13 may be sizedappropriately so as to accommodate at least the caps of the vialsidentified above.

It is contemplated that at least one nub (not shown) may project from asurface of respective guide surfaces 57, 59 of vial adapter 13 and whichare configured to snap-fit engage respective complementary detents orrecesses defined in slots 49, 51 of syringe adapter 11, or moreparticularly, an appropriately sized annular rib 49 a (see FIG. 3)formed in an inner surface of halves 43, 45 of housing 21 of syringeadapter 11. The interaction of the nubs of the guide surfaces 57, 59 ofvial adapter 13 and complementary detents or recesses defined in slots49, 51 or annular rib 49 a (see FIGS. 3 and 4) of syringe adapter 11provide a user with audible and/or tactile feedback that vial adapter 13and syringe adapter 11 are properly and fully connected to one another.

Turning now to FIGS. 1 and 11-14, patient push adapter 15 of the closedfluid transfer system 100 of the present disclosure, will be discussedin greater detail. In general, patient push adapter 15 connects totubing of a patient I.V. set permitting delivery of liquids directly tothe patient from a syringe “I” attached to the patient push adapter 15.

The patient push adapter 15 includes a body 301 having respective distaland proximal ends 303, 305. Body 301 of patient push adapter 15 ispreferably a one-piece molded plastic part. Distal end 303 of patientpush adapter 15 includes a male stem 19 defining a lumen 21, having aseal 23 supported across lumen 21, having guide pins 53, 55 projectingradially outward from on outer surface thereof, and having guidesurfaces 57, 59 projecting radially outward from on outer surfacethereof. Proximal end 305 of patient push adapter 15 includes aconventional luer connector 307 configured to accept a mating luerconnector of a patient I.V. set “IV” (see FIG. 1). Lumen 21 extendsthrough body 301, between seal 23 and luer connector 307, permittingfluid flow between the opening 63 of tip 61 of needle 27 and the luerconnector 307, when patient push adapter 15 is properly connected tosyringe adapter 11, as described above.

With reference to FIGS. 11-13, it is contemplated that at least one nub57 a, 59 a may project from a surface of respective guide surfaces 57,59 of patient push adapter 15 and which are configured to snap-fitengage respective complementary detents or recesses defined in slots 49,51 of syringe adapter 11, or more particularly, an appropriately sizedannular rib 49 a (see FIG. 3) formed in an inner surface of halves 43,45 of housing 25 of syringe adapter 11. The interaction of nubs 57 a, 59a, and complementary detents or recesses defined in slots 49, 51 orannular rib 49 a (see FIGS. 3 and 4) of syringe adapter 11 provide auser with audible and/or tactile feedback that patient push adapter 15and syringe adapter 11 are properly and fully connected to one another.

Guide surfaces 57, 59 of patient push adapter 15 provide a convenientand comfortable surface for a user to grip patient push adapter 15 andto rotate patient push adapter 15 relative to a conventional luer ofI.V. set.

Turning now to FIGS. 1 and 15-16, I.V. bag adapter 17 of the closedfluid transfer system 100 of the present disclosure, will be discussedin greater detail. In general, the I.V. bag adapter 17 enables liquid tobe delivered to, or extracted from, a conventional I.V. bag “B” (seeFIG. 1). The I.V. bag adapter 17 could also be used as a source ofventilation, permitting air to be delivered from a syringe “I” or othersource into the I.V. bag to more rapidly drain the I.V. bag “B” of itsliquid contents.

The I.V. bag adapter 17 includes a body 401 having respective distal andproximal ends 403, 405, and a spike 407 extending from body 401. Distalend 403 of I.V. bag adapter 17 includes a male stem 19 defining a lumen21, having a seal 23 supported across lumen 21, having guide pins 51, 53projecting radially outward from on outer surface thereof, and havingguide surfaces 57, 59 projecting radially outward from on outer surfacethereof. Body 401 of I.V. bag adapter 17 is preferably a one-piecemolded plastic part. Proximal end 405 of body I.V. bag adapter 17includes a conventional port 409 which receives a conventional taperedmale connector (not shown) of a conventional infusion chamber (notshown) into which liquid drips from the I.V. bag “B”. Spike 407 istapered between distal and proximal ends 403, 405 for insertion into aconventional port (not shown) of I.V. bag “B”.

Body 401 of I.V. bag adapter 17 includes two ducts 411, 413. First duct411 is essentially an extension of lumen 21 through spike 407 extendingto an opening 415 in spike 407 which would be within I.V. bag “B” whenI.V. bag adapter 17 is attached to the I.V. bag “B”. Second duct 413extends between a second opening 417 in spike 407 and a port 409 forattachment to the infusion chamber (not shown). As described above,opening 63 of tip 61 of needle 27 extends into lumen 21 of male stem 19,when I.V. bag adapter 17 is properly connected to syringe adapter 11, toextract or deliver liquid (or gas) through duct 411 while syringeadapter 11 is in the open state.

In accordance with the present disclosure, a component other than asyringe adapter 11 could be connected to male stem 19 of I.V. bagadapter 17 to deliver gas to I.V. bag “B”. Liquid medication deliveredthrough duct 411 may be mixed with the contents of the I.V. bag “B”. Theliquid in the I.V. bag “B” may then exit the I.V. bag “B” through port409 and into the infusion chamber for delivery to the patient.

With reference to FIGS. 15 and 16, it is contemplated that at least onenub 57 a, 59 a may project from a surface of respective guide surfaces57, 59 of I.V. bag adapter 17 and which are configured to snap-fitengage respective complementary detents or recesses defined in slots 49,51 of syringe adapter 11, or more particularly, an appropriately sizedannular channel 49 a (see FIG. 3) formed in an inner surface of halves43, 45 of housing 25 of syringe adapter 11. The interaction of nubs 57a, 59 a and complementary detents or recesses defined in slots 49, 51 orannular rib 49 a (see FIGS. 3 and 4) of syringe adapter 11 provide auser with audible and/or tactile feedback that I.V. bag adapter 17 andsyringe adapter 11 are properly and fully connected to one another.

Turning now to FIGS. 17-24, a syringe adapter, according to anotherembodiment of the present disclosure, is generally designated as 611.Syringe adapter 611 is substantially similar to syringe adapter 11 andthus will only be discussed in detail hereinbelow to the extentnecessary to describe differences in construction and operationtherebetween.

As seen in FIGS. 17-19, a respective distal or leading edge 631 a, 683 aof collar 631 and barrel 683 is chambered to thereby improve the matingof syringe adapter 611 with vial adapter 13, patient push adapter 15,and I.V. bag adapter 17. Additionally, a lead in for each throughportion 709, defined in an outer surface of collar 631, has beenchamfered so as to better guide the guide pins 53, 55 of any male stem19 into through portions 709.

As seen in FIG. 18, upper stop wall 703 of each track 699 of collar 631is oriented at an angle relative to a longitudinal axis of track 699. Inparticular, upper stop wall 703 is oriented at an angle “0” ofapproximately 85° relative to the longitudinal axis of track 699. It isalso contemplated that a distal-most surface 713 a of ribs 713 is alsooriented at an angle that substantially compliments the angle of upperstop wall 703. Such an angle of incline for upper stop wall 703 of eachtrack 699 of collar 631 and of distal-most surface 713 a of each rib713, facilitates the ability of collar 631 to rotate relative to housing25 of syringe adapter 611.

As illustrated in FIG. 19, collar 631 includes helical tracks 715, 717formed in an outer surface thereof. Each track 715, 717 defines a pitchor angle relative to a longitudinal axis of collar 631 equal toapproximately 50°. In this manner, the angle or pitch of helical tracks715, 717 of collar 631 is greater than the angle or pitch of helicaltracks 115, 117 of collar 31.

Referring now to FIGS. 21-24, syringe adapter 611 includes a lock-outfeature that prevents an inadvertent rotation of collar 631, relative tohousing 25, prior to engagement of seal 73 by the seal 23 of any of themale stems 19. The lock-out feature includes a shuttle 629 having arelatively larger diameter proximal portion 683 a of barrel 683transitioning to a relatively smaller diameter distal portion 683 b ofbarrel 683. The lock-out feature includes a pair of diametricallyopposed resilient lock arms 684, 685 formed in collar 631. Each lock arm684, 685 extends in a radial direction about collar 631 and includes afirst end 684 a, 685 a integrally formed or extending from collar 631,and a free second end 684 b, 685 b. The free second end 684 b, 685 b ofeach lock arm defines a tooth for engaging a respective rib 713.

In use, when shuttle 629 is in a non-depressed condition, as seen inFIGS. 21 and 22, proximal portion 683 a of barrel 683 of shuttle 629 isdimensioned so as to press against resilient lock arms 684, 685 formedin collar 631 or act as a barrier or wall against resilient lock arms684, 685 formed in collar 631, so as to prevent resilient lock arms 684,685 from deflecting radially inward and disengaging respective ribs 713.Since the tooth of lock arms 684, 685 is in engagement with respectiveribs 713 of housing 25, collar 631 is prevented from rotating relativeto housing 25 and thus prematurely enabling collar 631 from beingdepressed (after rotation) relative to housing 25.

As illustrated in FIGS. 23-24, in use, as shuttle 629 is pressed intocollar 631, upon a coupling with any of the male stems 19, as describedabove, distal portion 683 b of barrel 683 of shuttle 629 aligns with orcomes into registration with lock arms 684, 685 of collar 631. With theresilient lock arms 684, 685 overlying distal portion 683 b of barrel683 of shuttle 629, distal portion 683 b of barrel 683 of shuttle 629 isspaced a distance radially inward of lock arms 684, 685 by an amountsufficient to allow lock arms 684, 685 to deflect radially inward andsnap over respective ribs 713 as collar 631 is rotated relative tohousing 25.

As seen in FIGS. 22 and 24, lock arms 684, 685 are mirrored about aplane extending parallel to a longitudinal axis of collar 631 andextending substantially equally between lock arms 684, 685.

Referring now to FIGS. 25-31, closed fluid transfer system 100, of thepresent disclosure, may include a universal vial adapter 813. Generally,universal vial adapter 813 connects to various sized caps or necks ofvials holding a liquid to be extracted or into which liquid is to bedelivered. For example, universal vial adapter 813 may be configured toconnect to vials having either a 20 mm vial cap or a 28 mm vial cap.While 20 mm and 28 mm vial caps are identified, it is contemplated thatuniversal vial adapter 813 may be configured and dimensioned toaccommodate and/or connect to any size cap of any vial or the like.

Universal vial adapter 813 includes three, equally radially spaced apartfirst claws 815 a, 815 b, 815 c supported on a hub 814 and which areconfigured to engage an outer rim of a relatively smaller diametered cap(e.g., a 20 mm vial cap as seen in FIG. 25). Universal vial adapter 813also includes three, equally radially spaced apart second claws 816 a,816 b, 816 c supported on a hub 814 and which are configured to engagean outer rim of a relatively larger diametered cap (e.g., a 28 mm vialcap as seen in FIG. 28). Each second claw 816 a, 816 b, 816 c isinterposed between adjacent first claws 815 a, 815 b, 815 c.

It is contemplated that each claw 815 a, 815 b, 815 c and each claw 816a, 816 b, 816 c is biased to a closed condition.

It is further contemplated that hub 814 is slidably disposed within base201 of universal vial adapter 813. Universal vial adapter 813 includes alocking system including at least one first latch arm 817 having ashoulder 817 a which engages a first shoulder 201 a of base 201 when hub814 is in a fully pressed-in condition. The locking system of universalvial adapter 813 includes at least one second latch arm 818 having ashoulder 818 a which engages a second shoulder 201 b of base 201 whenhub 814 is in a fully non-pressed-in condition.

In use, the at least one second latch arm 818 of the locking systemmaintains hub 814 in the fully non-pressed-in condition until arelatively smaller cap is fully engaged by first claws 815 a, 815 b, 815c or until relatively larger cap is fully engaged by second claws 816 a,816 b, 816 c. Once the cap is fully engaged by first claws 815 a, 815 b,815 c or second claws 816 a, 816 b, 816 c, the at least one second latcharm 818 of the locking system disengages from second shoulder 201 b ofbase 201, allowing hub 814 to be moved to the pressed-in condition. Whenhub 814 is moved to the pressed-in condition, the shoulder 817 a of theat least one first latch arm 817 engages the first shoulder 201 a ofbase 201 to maintain hub 814 in the pressed-in condition.

An important aspect of the present disclosure is the alignment andcontact of seal 73 of syringe adapters 11 or 611 with seal 23 of malestems 19 of patient push adapter 13, vial adapters 15 and 815, and I.V.bag adapter 17. Ensuring that seals 73 and 23 are in proper alignmentwith one another is important to ensure that needle 27 penetratesthrough both seals 73 and 23 upon complete coupling/connecting ofsyringe adapters 11, 611 with patient push adapter 13, vial adapters 15and 815, and I.V. bag adapter 17.

Another important aspect of the present disclosure is the ability of theuser to swab, wipe, clean and/or disinfect seals 73 and 23 prior to orfollowing their use.

Also in accordance with the present disclosure, each seal 23 and 73 isprovided with a constant pressure radially inward along an entire lengthof seal 23, 73 such that the distal and proximal surfaces of seals 23,73 are convex or arc outward. As such, the seal to seal contact betweenabutting seals 23 and 73 is improved.

While the above disclosure and related figures illustrate syringes,vials, I.V. sets, and I.V bags as exemplary embodiments, it isenvisioned and within the scope of the present disclosure that any ofthe adapters described herein may be used in cooperation with any fluidcontainer, such as, for example, bottles, test tubes, trays, tubs, vats,jars, bathes, pools, pressure vessels, balloons, ampoules, etc.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplifications ofpreferred embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appendedthereto.

What is claimed is:
 1. A closed fluid transfer system for fluidlyinterconnecting a syringe to at least one of a patient I.V. set, a vialand an I.V. bag, the closed fluid transfer system comprising: a syringeadapter including: a housing defining an open distal end and an openproximal end, the housing defining a pair of opposed longitudinallyextending slots opening from the open distal end of the housing, thehousing including a pair of opposed longitudinally extending ribsprojecting from an inner surface thereof; a base supported in the openproximal end of the housing and including a luer connector; a collarslidably and rotatably supported in the housing, the collar defining alongitudinal opening therethrough, the collar defining a pair of opposedL-shaped tracks formed in an outer surface thereof and configured toreceive a respective longitudinally extending rib therein, the collardefines a pair of opposed helical tracks opening from a distal surfaceof the collar, the opposed helical tracks being aligned with arespective slot of the housing when the collar is in a distal-mostposition; a shuttle slidably extending through longitudinal opening ofthe collar, the shuttle defining a lumen extending longitudinallytherethrough; a barrel supported on and extending over a distal end ofthe shuttle, the barrel defining a central opening aligned with thelumen of the shuttle; a biasing member interposed between the collar andthe shuttle for urging the collar away from the shuttle; a sealinterposed between the shuttle and the barrel, wherein the seal extendsacross the lumen of the shuttle and the central opening of the barrel;and a needle defining a lumen therethrough, the needle having a proximalend supported in the base such that the lumen of the needle is in fluidcommunication with the luer connector, the needle having a sharpeneddistal tip disposed within the lumen of the shuttle when the shuttle isin a distal-most position; and another adapter for fluidlyinterconnecting the syringe adapter to one of the patient I.V. set, thevial and the I.V. bag, the another adapter including: a male stem forselectively connecting to and insertion into the open distal end of thesyringe adapter, the male stem defining a lumen extending therethrough;a pair of opposed guide pins extending radially outward from the malestem; a pair of opposed guide surfaces extending radially outward fromthe male stem at a location proximal of the guide pins and being inregistration with the guide pins; and a seal extending across the lumenof the male stem; wherein the syringe adapter is movable from a closedstate to an open state; wherein in the closed state the tip of theneedle is disposed within the lumen of the shuttle, the shuttle isdisposed at the distal-most position, and the collar is disposed at adistal-most position; and wherein the syringe adapter is movable fromthe closed state to the open state by: inserting the guide pins of themale stein of the another adapter into the respective slots of thehousing of the syringe adapter, whereby the seal of the another adapterabuts the seal of the syringe adapter; advancing the male stein of theanother adapter into the open distal end of the housing such that theguide pins enter into the respective helical track of the collar torotate the collar relative to the housing of the syringe and align theribs of the housing with a through portion of the collar; and furtheradvancing the male stem of the another adapter into the open distal endof the housing causes the collar to move proximally which causes theshuttle to move proximally until the tip of the needle penetratesthrough the abutting seals, whereby the syringe adapter is in the openstate and fluidly interconnects the syringe with the another adapter. 2.The closed fluid transfer system according to claim 1, wherein each sealis made from polyisoprene.
 3. The closed fluid transfer system accordingto claim 1, wherein the another adapter is a vial adapter configured tofluidly interconnect the syringe adapter to the vial, the vial adapterincluding: a base defining an opening having a plurality of retainersextending around the opening of the base and being configured tosnap-fit connect to a neck of the vial, the base defining a lower innerannular rim and an outer annular rim and a cavity therebetween; a coversupported on the outer rim of the base, wherein an expansion chamber isdefined within the cover and the base; an adapter support situatedwithin the cavity of the base, the adapter support including: an annularflange for seating on the lower inner annular rim of the base andforming a fluid tight seal therebetween; an annular wall extending fromthe annular flange and defining an upper inner annular rim, wherein thecover is also supported on the upper inner annular rim; the male stemextending in a first direction from the annular flange; and a spikeextending in a second direction from the annular flange, wherein thespike extends into the opening of the base, wherein the spike includes afirst lumen being in fluid communication with the lumen of the malestem, and wherein the spike includes a second lumen being in fluidcommunication with the expansion chamber; and a bladder extendingbetween the inner upper annular rim and the outer annular rim of thebase; wherein the syringe adapter is movable from the closed state tothe open state by: inserting the guide pins of the male stem of the vialadapter into the respective slots of the housing of the syringe adapter,whereby the seal of the vial adapter abuts the seal of the syringeadapter; advancing the male stem of the vial adapter into the opendistal end of the housing such that the guide pins enter into therespective helical track of the collar to (1) rotate the collar relativeto the housing of the syringe adapter and (2) align the ribs of thehousing with a through portion of the collar; and further advancing themale stem of the vial adapter into the open distal end of the housingcausing the collar to move proximally which causes the shuttle to moveproximally until the tip of the needle penetrates through the abuttingseals, whereby the syringe adapter is in the open state and fluidlyinterconnects the syringe with the vial adapter.
 4. The closed fluidtransfer system according to claim 3, wherein the spike of the vialadapter penetrates a septum of the vial upon a connection of the base ofthe vial adapter to a neck of the vial.
 5. The closed fluid transfersystem according to claim 4, wherein when the syringe is connected tothe syringe adapter, and when the syringe adapter is connected to thevial adapter, and when the vial adapter is connected to the vial, thesyringe is in closed fluid communication with the vial.
 6. The closedfluid transfer system according to claim 4, wherein when the syringe isconnected to the syringe adapter, and when the syringe adapter isconnected to the vial adapter, the tip of the needle of the syringeadapter penetrates the abutting seals of the syringe adapter and thevial adapter and when the vial adapter is connected to the vial, thesyringe is in closed fluid communication with the vial.
 7. The closedfluid transfer system according to claim 4, wherein air from the syringeis injectable into a cavity of the vial adapter defined between thebladder, and the base and the adapter support, through a fluid passagedefined by the needle of the syringe adapter, the lumen of the malestem, the first lumen of the spike, the vial and the second lumen of thespike.
 8. The closed fluid transfer system according to claim 1, whereinthe another adapter is a patient push adapter configured to fluidlyinterconnect the syringe adapter to the I.V. set, the patient pushadapter including: a body portion having a the male stem disposed at afirst end thereof and a patient push adapter luer connector at a secondend thereof, wherein the patient push adapter luer connector is in fluidcommunication with the lumen of the male stem; wherein the syringeadapter is movable from the closed state to the open state by: insertingthe guide pins of the male stem of the patient push adapter into therespective slots of the housing of the syringe adapter, whereby the sealof the patient push adapter abuts the seal of the syringe adapter;advancing the male stem of the patient push adapter into the open distalend of the housing such that the guide pins enter into the respectivehelical track of the collar to rotate the collar relative to the housingof the syringe and align the ribs of the housing with a through portionof the collar; and further advancing the male stem of the patient pushadapter into the open distal end of the housing causing the collar tomove proximally which causes the shuttle to move proximally until thetip of the needle penetrates through the abutting seals, whereby thesyringe adapter is in the open state and fluidly interconnects thesyringe with the I.V. set.
 9. The closed fluid transfer system accordingto claim 8, wherein when the syringe is connected to the syringeadapter, and when the syringe adapter is connected to the patient pushadapter, the tip of the needle of the syringe adapter penetrates theabutting seals of the syringe adapter and the patient push adapter andwhen the patient push adapter is connected to the I.V. set, the syringeis in closed fluid communication with the I.V. set.
 10. The closed fluidtransfer system according to claim 1, wherein the another adapter is anI.V. bag adapter configured to fluidly interconnect the syringe adapterto the I.V. bag, the I.V. bag adapter including: a body portion having athe male stem extending therefrom; a spike extending from a first end ofthe body portion, the spike defining a first lumen and a second lumenextending therethrough, wherein the first lumen of the spike is in fluidcommunication with the lumen of the male stem; an I.V. bag adapter luerconnector disposed at a second end of the body portion and being influid communication with the second lumen of the spike; wherein thesyringe adapter is movable from the closed state to the open state by:inserting the guide pins of the male stem of the I.V. bag adapter intothe respective slots of the housing of the syringe adapter, whereby theseal of the I.V. bag adapter abuts the seal of the syringe adapter;advancing the male stem of the I.V. bag adapter into the open distal endof the housing such that the guide pins enter into the respectivehelical track of the collar to rotate the collar relative to the housingof the syringe and align the ribs of the housing with a through portionof the collar; and further advancing the male stem of the I.V. bagadapter into the open distal end of the housing causing the collar tomove proximally which causes the shuttle to move proximally until thetip of the needle penetrates through the abutting seals, whereby thesyringe adapter is in the open state and fluidly interconnects thesyringe with the I.V. bag.
 11. The closed fluid transfer systemaccording to claim 10, wherein when the syringe is connected to thesyringe adapter, and when the syringe adapter is connected to the I.V.bag adapter, the tip of the needle of the syringe adapter penetrates theabutting seals of the syringe adapter and the I.V. bag adapter and whenthe I.V. bag adapter is connected to the I.V. bag, the syringe is inclosed fluid communication with the I.V. bag.
 12. The closed fluidtransfer systems according to claim 1, wherein the syringe adapterincludes a lock out system having: a collar including at least one lockarm extending in a radial direction about the collar, wherein each lockarm includes a first end integral with the collar and a second free enddefining a tooth extending radially outward and being dimensioned tocontact a longitudinally extending rib of the housing; and a shuttleincluding a relatively larger diameter proximal portion and a relativelysmaller diameter distal portion; wherein, when the shuttle is in thedistal-most position, each lock arm is in registration with therelatively larger diameter portion of the shuttle thereby inhibitingeach lock arm from deflecting radially inward; and wherein, when theshuttle is moved proximally, the relatively smaller diameter portion ofthe shuttle is moved into registration with each lock arm therebypermitting each lock arm to deflect radially inward and to permit thecollar to rotate.